The US Food and Drug Administration (FDA) has accepted for review the complete response submission made by Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc., to the new drug application (NDA) for its long-acting testosterone undecanoate injection, AVEED, intended for men diagnosed with hypogonadism. In connection with the acceptance, the FDA assigned Endo's NDA a new Prescription Drug User Fee Act (PDUFA) action date of Feb. 28, 2014.
"We are pleased that our complete response was accepted by the FDA," said Ivan Gergel, executive vice president of research and development and chief scientific officer of Endo. "We look forward to working with the FDA to complete the review process and make this treatment option available to appropriate male patients in the US diagnosed with hypogonadism."
Endo Health Solutions Inc. (Endo) is a specialty healthcare company with four distinct business segments that are focused on branded and generic pharmaceuticals, devices and services, each providing quality products to our customers while improving the lives of patients.